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Tipsep-T4(ria) T4 Radioimmunoassay

FDA 510(k)

Class II (US FDA 510(k))

510(k) K792599

by Nuclear Diagnostics, Inc.

Identifiers

510(k) Number
K792599 FDA 510(k)
FDA Product Code
CDX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1700 FDA 510(k)
Regulation Number
862.1700 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Tipsep-T4 Radioimmunoassay is a diagnostic device designed to measure total thyroxine (T4) levels in plasma and tissues. It utilizes radioimmunoassay techniques to assist clinical laboratories in the diagnosis of thyroid disorders.

This device is regulated under FDA 510(k) clearance K792599 and is classified as a Class 2 medical device for clinical chemistry applications. It is intended for professional use within a clinical laboratory setting.

Frequently asked questions

What is the primary clinical use of the Tipsep-T4 Radioimmunoassay?

This device is designed for use in clinical laboratories to measure total thyroxine (T4) levels in human plasma and tissue samples. By quantifying these levels, the assay assists healthcare professionals in the diagnosis of various thyroid disorders.

Who is the intended user for this diagnostic device?

The Tipsep-T4 Radioimmunoassay is intended exclusively for professional use within a clinical laboratory setting. It requires trained personnel to perform the radioimmunoassay techniques necessary to obtain accurate diagnostic results.

What is the regulatory status of the Tipsep-T4 Radioimmunoassay?

The device is regulated under FDA 510(k) clearance number K792599. It is classified as a Class 2 medical device for clinical chemistry applications, having been determined to be substantially equivalent to other devices in its category.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: tipsep-t4 ria t4 radioimmunoassay - Nuclear Diagnostics | FDA Evidence ..., TIPSEP-T4(RIA) T4 RADIOIMMUNOASSAY (K792599) — FDA 510(k) | Innolitics, PDF K792599 TIPSEP-T4(RIA) T4 RADIOIMMUNOASSAY - 510kdatabase.net, TIPSEP-T4(RIA) T4 RADIOIMMUNOASSAY 510(k) K792599 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nuclear Diagnostics, Inc.

Sources (1)

  • FDA 510(k) K792599 24 fields · synced Sep 22, 2026